Jotec has announced that it has completed enrolment in the PLIANT (Patients with iliac aneurysm undergoing endovascular stenting with a new generation of low profile E-liac stent graft system) study. PLIANT is an observational, prospective, non-randomised, multicentre, single-arm study to evaluate clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of unilateral or bilateral aorto-iliac or isolated iliac aneurysm.
The main target of the study is the exclusion of aneurysm with primary patency of the internal iliac artery and external iliac artery on the iliac implantation side. Jan Brunkwall, University Hospital Cologne, Germany, is the principal investigator.
According to Jotec, patient enrolment has now been completed with more than 45 patients recruited and treated with the E-liac stent graft. Follow-up and data collection is planned for each patient up to 36 months from intervention and study completion is expected in 2019.
In a press release, Jotec stated that the E-liac Stent Graft System is a new generation of an iliac side branch device incorporating numerous innovative features such as high 3D flexibility, a free standing side branch as well as excellent X-ray visibility. Various stent graft configurations are available to treat a broad range of challenging anatomies. The low profile 18F delivery system is adapted for cross-over manoeuvres and equipped with the proven Squeeze-to-Release deployment mechanism. More information about the product and can be obtained at www.jotec.com.